FDA Grants Fast Track Designation to ONC201 for the Treatment of Adult Recurrent H3 K27M-mutant High-Grade Glioma

On November 12, 2018 Oncoceutics, Inc., a clinical-stage drug discovery and development company with a novel class of compounds that selectively target G protein-coupled receptors for oncology reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Oncoceutics’ investigational cancer drug ONC201 for the treatment of adult recurrent H3 K27M-mutant high-grade glioma (Press release, Oncoceutics, NOV 12, 2018, View Source [SID1234558364]).

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The FDA’s Fast Track designation is intended to facilitate the development of new therapies for serious or life-threatening diseases or conditions and with the potential to address unmet medical needs for such diseases or conditions. A company with an investigational medicine receiving Fast Track designation may be eligible for more frequent communications with the FDA and may receive an expedited review of the new drug application.

"It is exciting to see a therapeutic option emerge from translational research into a formal clinical development program for a devastating disease such as H3 K27M high-grade glioma," said Patrick Y. Wen, MD, Director of the Center For Neuro-Oncology at Dana-Farber Cancer Institute. "Novel therapeutic approaches are important for our recurrent midline glioma patients who currently do not have effective treatment options."